PROTOCOL UPDATE PATIENT HANDOUTS

Transcription

1 Volume 2, Number 2 for health professionals who care for cancer patients February 1999 I NSIDE THIS ISSUE Benefit drug list: Paclitaxel and carboplatin (GOOVCATX), tamoxifen Clinical trial update: Letrozole vs placebo (NCIC CTG MA17) Drug update: Docetaxel, mitomycin Nursing practice tips: Paclitaxel Patient handouts: Mechlorethamine Protocol update: BRAVDOC, GIRFLOW, GOENDCAT, GOOVCATX, GUBEP, GUMXP, LYRITUX FAX request form and IN TOUCH phone list are provided if additional information is needed. BENEFIT DRUG LIST Fast-tracked new programs funded by the BCCA oncology drug budget: Extreme risk ovarian cancer patients may now be treated with paclitaxel (Taxol ) and carboplatin as an option to paclitaxel and cisplatin. See GOOVCATX protocol summary. The Gynecological Tumour Group will send out the formal notification. The Breast Tumour Group s request for an extension of their adjuvant use of tamoxifen has been approved. Pre- or post-menopausal patients who have node negative, estrogen receptor positive tumours which are either Grade I or Grade II and sizes cm may now be treated with five years of tamoxifen 20 mg daily. A formal notification will ensue from the Breast Tumour Group. Susan O Reilly, MB, FRCPC Provincial Systemic Program Leader PROTOCOL UPDATE BRAVDOC revised (non-pvc equipment required) palliative therapy for metastatic breast cancer using docetaxel (Taxotere ) GIRFLOW new, flow chart for rectal adjuvant and local advanced studies GOENDCAT revised (Day 7 CBC deleted, exclusions revised) therapy for primarily advanced or recurrent endometrial cancer using carboplatin and paclitaxel GOOVCATX revised (Class II status) primary treatment of visible residual (extreme risk) invasive epithelial ovarian cancer in ambulatory care settings GUBEP (interim version) therapy for intermediate risk non-seminomatous testicular cancer using bleomycin, etoposide and cisplatin GUMXP revised (optional reduced starting dose) therapy for hormone resistant prostate cancer using mitoxantrone and low dose prednisone LYRITUX revised (fatal cytokine release syndrome warning added) therapy for CD20 postive lymphoma using rituximab via Health Canada s Special Access Program PATIENT HANDOUTS Mechlorethamine revised (application instructions) DRUG UPDATE Docetaxel (Taxotere ) Requires non-pvc Equipment The docetaxel product monograph was revised and now recommends that non-pvc equipment be used for infusion solutions and administration. Effective immediately, non-pvc infusion bags and administration sets are a BC Cancer Agency standard for docetaxel administration. British Columbia Cancer Agency Provincial Systemic Therapy Program Update

2 Mitomycin Concentration A 0.5 mg/ml solution is now the BC Cancer Agency standard for mitomycin IV bolus administration. CLINICAL TRIAL UPDATE Phase III Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen (NCIC CTG MA17) Standard practice calls for tamoxifen to be discontinued after 5 years of use in the adjuvant setting. In this study, women are randomized to receive either letrozole 2.5 mg (an oral nonsteroidal aromatase inhibitor) or placebo daily for a further 5 years. The primary outcomes are diseasefree and overall survival. Secondary outcomes include contralateral breast cancer incidence, long term safety of letrozole, bone fracture incidence and overall quality of life. The study is open to women with the following eligibility criteria: post-menopausal women with either estrogen receptor positive or unknown receptor status breast cancer randomization within 3 months following completion of 5 years of adjuvant Tamoxifen therapy no evidence of breast cancer recurrence at study entry 2 NURSING PRACTICE TIPS Paclitaxel (Taxol ) Administration Paclitaxel is used for gynecological and metastatic breast cancers. Typically, patients receive paclitaxel in an ambulatory setting via an IV infusion over 3 hours. Intravenous premedications are given 30 minutes prior to the paclitaxel to reduce the potential for hypersensitivity reactions. Nurses around the province have been asking questions related to IV equipment set-up for paclitaxel administration and sequencing of premedications. The following section addresses these issues. IV Set Up Paclitaxel is formulated in Cremophor EL that leaches the plasticizer from standard polyvinyl chloride (PVC) IV tubing. Therefore, non-pvc tubing is used. This non-pvc tubing is lined with polyethelene that prevents the paclitaxel from coming in contact with the PVC. Additionally, a 22 micron filter is attached to the non-pvc tubing. Figure 1 displays an appropriate IV set-up, where paclitaxel becomes the primary line (A). A second solution set (B) is attached at the lowest port, allowing for continued venous access in the event that the paclitaxel infusion needs to be interrupted. In this way, the patient s IV site may be assessed for patency with normal saline (NS), administered via the secondary line, and then the paclitaxel infusion may be initiated via the primary line. Most eligible patients are being followed by their family physicians at this time. A protocol summary is available by Fax request. Please contact one of the following investigators for additional information: Dr. Tamara Shenkier (VCC) L Dr. Brian Norris (FVCC) L Dr. Susan Ellard (CCSI) L Dr. Sharon Allan (VICC) L Dr. Chris Williams (Nanaimo) Taxol Volumetric Infusion Pump (op tional) 0.22 micron Filter N S Flush Additional information is available via fax-back. N on-pvc Patient Lowest port Fig. 1 Equipment Set-up

3 Paclitaxel may be administered through: peripheral Teflon IV catheter peripheral winged needle infusion set (butterfly needle) central venous access devices (e.g. Hickman- Broviac, PICC, PAS ports, IVAD, etc.) Huber point needle with pre-attached extension tubing Premedication Sequencing Hypersensitivity reactions to paclitaxel are common if premedications are not used. Dexamethasone, diphenhydramine and ranitidine are administered to prevent a reaction. Nurses have raised issues surrounding the sequencing of these premedications due to the recent practice change from oral dexamethasone 6 and 12 hours pre-paclitaxel to IV dexamethasone 30 minutes pre-paclitaxel. To date, the decision regarding sequencing is arbitrary and we suggest that pre-medications be given in the following order: dexamethasone 20 mg IV in 50 ml NS or D5W over 15 minutes then diphenhydramine 50 mg IV and ranitidine 50 mg IV mixed together in ml NS or D5W over minutes We will continue to investigate this issue and will update nurses when there is evidence upon which to base a decision. Tracy Truant, RN, MSN Regional Nurse Leader: Education and Practice, VCC References 1. Brown J et al. Administering Taxol (paclitaxel) for injection concentrate in the outpatient setting: the BCCA experience. Bristol-Myers, Princeton NJ, BCCA Nursing Practice Reference Manual, C-252, P Editorial Review Board Robin O Brien PharmD (Editor) Sharon Allan MD Sandi Broughton BA(Econ), MSc Jack Chritchley MD Esther Green RN, MSc Dianne Kapty BSc(Pharm) Kelly Uyeno CGA Gigi Concon (Secretary)

4 BCCA SYSTEMIC THERAPY UPDATE FAX REQUEST FORM FAX (604) TO SUBSCRIBE: FAX OR YOUR REQUEST OR LOCAL FOR URGENT REQUESTS PLEASE CALL (604) LOCAL 2247 OR TOLL-FREE IN BC LOCAL 2247 I WOULD PREFER TO RECEIVE THIS INFORMATION VIA: (Word Fax ( ) Attn: UPDATES Please Fax-Back information below: All items Clinical Trial: MA17 Letrozole versus placebo Patient Handouts: Mechlorethamine revised (application instructions) Protocol Summaries: INDEX BRAVDOC GIRFLOW GOENDCAT GOOVCATX GUBEP GUMXP LYRITUX Reimbursement Benefit Drug List (01 Nov 98) Class 2 Form (01 Nov 98)

5 5 RADIATION CANCER CENTRE ACCESS BULLETIN UPDATES LOCATION Clinical Trials: MA17 H:\everyone\systemic\chemo\update\Feb1999\MA17 Patient Handouts: H:\everyone\systemic\chemo\Pt_Educ Mechlorethamine Revised Cancer Drug Manual at Protocol Summaries H:\everyone\systemic\chemo\Protocol BRAVDOC Revised H:\everyone\systemic\chemo\Protocol\Breast\Bravdoc GIRFLOW New H:\everyone\systemic\chemo\Protocol\GI\Girflow GOENCAT Revised H:\everyone\systemic\chemo\Protocol\Gyne\Goendcat GOOVCATX Revised H:\everyone\systemic\chemo\Protocol\Gyne\Goovcatx GUBEP New H:\everyone\systemic\chemo\Protocol\GU\Gubep GUMXP Revised H:\everyone\systemic\chemo\Protocol\GU\Gumxp LYRITUX Revised H:\everyone\systemic\chemo\Protocol\Lymphoma\Lyritux Reimbursement H:\everyone\systemic\chemo\Reimburs Benefit Drug List H:\everyone\systemic\chemo\Reimburs\Benefit.doc Class 2 Form H:\everyone\systemic\chemo\Reimburs\Class2.doc For easy access, double-click your systemic chemo icon. We appreciate your comments. Write us at bulletin@bccancer.bc.ca IN TOUCH IN TOUCH bulletin@bccancer.bc.ca BC Cancer Agency (604) Toll-Free 1-(800) Cancer Centre for the Southern Interior (250) Toll-Free 1-(888) (CCSI) Fraser Valley Cancer Centre (FVCC) (604) Vancouver Cancer Centre (VCC) (604) Toll-Free 1-(800) Vancouver Island Cancer Centre (VICC) (250) Toll-Free 1-(800) Communities Oncology Network (604) Ext 2744 Toll-Free 1-(800) Ext 2744 Nursing Professional Practice (604) Ext 2623 Toll-Free 1-(800) Ext 2623 Pharmacy Professional Practice (604) Ext 2247 Toll-Free 1-(800) Ext 2247 Provincial Systemic Program (604) Ext 2247 Toll-Free 1-(800) Ext 2247 Francis Hu, CON Pharmacist (604) Ext 2515 francish@bccancer.bc.ca Robin O Brien, Update Editor (604) Ext 3028 robrien@bccancer.bc.ca